亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial

医学 彭布罗利珠单抗 易普利姆玛 临床终点 内科学 不利影响 队列 临床试验 实体瘤疗效评价标准 黑色素瘤 胃肠病学 外科 耐火材料(行星科学) 临床研究阶段 免疫疗法 癌症 天体生物学 物理 癌症研究
作者
Caroline Robert,Antoni Ribas,Jedd D. Wolchok,F. Stephen Hodi,Omid Hamid,Richard Kefford,Jeffrey S. Weber,Anthony M. Joshua,Wen-Jen Hwu,Tara C. Gangadhar,Amita Patnaik,Roxana Dronca,Hassane M. Zarour,Richard W. Joseph,Peter D. Boasberg,Bartosz Chmielowski,Christine Mateus,Michael A. Postow,Kevin Gergich,Jeroen Elassaiss‐Schaap
出处
期刊:The Lancet [Elsevier BV]
卷期号:384 (9948): 1109-1117 被引量:1726
标识
DOI:10.1016/s0140-6736(14)60958-2
摘要

The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.In an open-label, international, multicentre expansion cohort of a phase 1 trial, patients (aged ≥18 years) with advanced melanoma whose disease had progressed after at least two ipilimumab doses were randomly assigned with a computer-generated allocation schedule (1:1 final ratio) to intravenous pembrolizumab at 2 mg/kg every 3 weeks or 10 mg/kg every 3 weeks until disease progression, intolerable toxicity, or consent withdrawal. Primary endpoint was overall response rate (ORR) assessed with the Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) by independent central review. Analysis was done on the full-analysis set (all treated patients with measurable disease at baseline). This study is registered with ClinicalTrials.gov, number NCT01295827.173 patients received pembrolizumab 2 mg/kg (n=89) or 10 mg/kg (n=84). Median follow-up duration was 8 months. ORR was 26% at both doses--21 of 81 patients in the 2 mg/kg group and 20 of 76 in the 10 mg/kg group (difference 0%, 95% CI -14 to 13; p=0·96). Treatment was well tolerated, with similar safety profiles in the 2 mg/kg and 10 mg/kg groups and no drug-related deaths. The most common drug-related adverse events of any grade in the 2 mg/kg and 10 mg/kg groups were fatigue (29 [33%] vs 31 [37%]), pruritus (23 [26%] vs 16 [19%]), and rash (16 [18%] vs 15 [18%]). Grade 3 fatigue, reported in five (3%) patients in the 2 mg/kg pembrolizumab group, was the only drug-related grade 3 to 4 adverse event reported in more than one patient.The results suggest that pembrolizumab at a dose of 2 mg/kg or 10 mg/kg every 3 weeks might be an effective treatment in patients for whom there are few effective treatment options.Merck Sharp and Dohme.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
2秒前
集典完成签到 ,获得积分10
4秒前
Ultraman45发布了新的文献求助10
7秒前
Ultraman45发布了新的文献求助10
18秒前
19秒前
量子星尘发布了新的文献求助10
23秒前
24秒前
Ultraman45完成签到,获得积分10
25秒前
NexusExplorer应助江洋大盗采纳,获得10
26秒前
meow完成签到 ,获得积分10
31秒前
情怀应助lf采纳,获得10
33秒前
42秒前
43秒前
hta_chen完成签到,获得积分10
43秒前
lf发布了新的文献求助10
46秒前
hta_chen发布了新的文献求助10
48秒前
52秒前
Zhy发布了新的文献求助10
55秒前
李健的小迷弟应助He采纳,获得20
55秒前
繁荣的青旋完成签到,获得积分10
1分钟前
1分钟前
1分钟前
嘟嘟嘟嘟完成签到 ,获得积分10
1分钟前
Zhy完成签到,获得积分10
1分钟前
量子星尘发布了新的文献求助10
1分钟前
科研通AI2S应助科研通管家采纳,获得10
1分钟前
1分钟前
lf发布了新的文献求助10
1分钟前
lei029发布了新的文献求助10
1分钟前
1分钟前
1分钟前
Tonyzad完成签到,获得积分10
1分钟前
He发布了新的文献求助20
1分钟前
江洋大盗发布了新的文献求助10
1分钟前
CATH完成签到 ,获得积分10
1分钟前
lei029完成签到,获得积分10
1分钟前
kingJames发布了新的文献求助10
2分钟前
kingJames完成签到,获得积分10
2分钟前
慕青应助555557采纳,获得10
2分钟前
迷路的八宝粥完成签到,获得积分10
2分钟前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3976619
求助须知:如何正确求助?哪些是违规求助? 3520720
关于积分的说明 11204567
捐赠科研通 3257359
什么是DOI,文献DOI怎么找? 1798716
邀请新用户注册赠送积分活动 877897
科研通“疑难数据库(出版商)”最低求助积分说明 806613